January 2007 – Federal Register Recent Federal Regulation Documents

The Coast Guard is withdrawing its notice of proposed rulemaking (NPRM) concerning the establishment of safety zones throughout the Great Lakes for the purpose of conducting gunnery training. The Coast Guard is authorized to conduct training in realistic conditions and in locations including in, on, and over the internal waters of the United States. In order to maximize safety, the NPRM proposed establishing safety zones in order to maintain Coast Guard control over the training area during training periods. This NPRM is being withdrawn, however, because of comments received from the public regarding the number and location of the proposed safety zones, the frequency of use, notification procedures as well as other concerns raised by the public. There will be no further gunnery training on the Great Lakes to satisfy non-emergency training requirements unless we first propose to the public and then publish a final rule. Because the Coast Guard is mandated to provide for the safety and security of the more than 30 million people in Great Lakes region, the critical infrastructure that make up the Great Lakes system, and the vessels that use it, we are evaluating all available options, including a new NPRM for gunnery training.

We are proposing to amend the regulations to add that portion of the Patagonia region of Argentina located south of latitude 42[deg] south (Patagonia South) to the list of regions considered free of rinderpest and foot-and-mouth disease (FMD). We are taking this action because we have determined that Patagonia South is free of rinderpest and FMD. We are also proposing to add that region to the list of regions that are subject to certain import restrictions on meat and meat products because of their proximity to or trading relationships with rinderpest-or FMD-affected countries. These actions would update the disease status of Patagonia South with regard to rinderpest and FMD while continuing to protect the United States from an introduction of those diseases by providing additional requirements for any meat and meat products imported into the United States from Patagonia South.

The Coast Guard hereby amends two special anchorage areas in Camden Harbor, Camden, Maine. This action is necessary to facilitate safe navigation in that area and provide safe and secure anchorages for vessels not more than 65 feet in length. This action is intended to increase the safety of life and property in Camden Harbor, improve the safety of anchored vessels, and provide for the overall safe and efficient flow of vessel traffic and commerce.

On November 2, 2001 (66 FR 55603), the Nuclear Regulatory Commission (NRC) published for public comment a petition for rulemaking (PRM) filed by Scott Portzline, Three Mile Island Alert. The petitioner requested that the NRC regulations governing physical protection of plants and materials be amended to require NRC licensees to post at least one armed guard at each entrance to the ``owner controlled areas'' (OCAs) surrounding all U.S. nuclear power plants. The petitioner states that this should be accomplished by adding armed site protection officers (SPOs) to the security forcesnot by simply moving SPOs from their protected area (PA) posts to the OCA entrances. The petitioner believes that its proposed amendment would provide an additional layer of security that would complement existing measures against radiological sabotage and would be consistent with the long- standing principle of defense-in-depth. This document informs the public that PRM-73-11 and public comments received in response to the above notice will be considered in a proposed rulemaking, ``Power Reactor Security Requirements,'' published in the Federal Register on October 26, 2006 (71 FR 62664). This rulemaking proposes extensive revisions to the NRC regulations in 10 CFR parts 50, 72, and 73 that address security requirements for nuclear power reactor licensees and certain materials licensees. The comment period on that proposed rule expires on February 23, 2007. Because the public has already had opportunity to comment on PRM-73-11, the NRC is requesting that comments focus on the proposed rule provisions in light of the subject PRM. Refer to the preamble of the proposed rule for instructions on how to provide comments.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to: Include vitamin D so that, in addition to claims for calcium and osteoporosis, additional claims can be made for calcium and vitamin D and osteoporosis; eliminate the requirement in Sec. 101.72(c)(2)(i)(A) (21 CFR 101.72(c)(2)(i)(A)) that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; eliminate the requirement in Sec. 101.72(c)(2)(i)(B) that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis; eliminate the requirement in Sec. 101.72(c)(2)(i)(C) that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; and eliminate the requirement in Sec. 101.72(c)(2)(i)(E) that the claim include a statement that reflects the limit of the benefits derived from dietary calcium intake, when the level of calcium in the food exceeds a set threshold level. FDA is taking these actions, in part, in response to a health claim petition submitted by The Beverage Institute for Health and Wellness, LLC. Elsewhere in this issue of the Federal Register, FDA is withdrawing certain proposed amendments to a proposed rule that published in the Federal Register of December 21, 1995 (60 FR 66206) related to the calcium and osteoporosis health claim.

The Coast Guard is changing the operating regulation governing the operation of the Southern Boulevard (SR 700/80) Bridge across the Atlantic Intracoastal Waterway, mile 1024.7, Palm Beach, Florida. The rule will require the drawbridge to open twice an hour. The schedule is based on requests from vessel operators along the Atlantic Intracoastal Waterway. The schedule will require the bridge to open on the quarter and three quarter hour and would meet the reasonable needs of navigation while not impacting vehicular traffic.

NMFS announces that the Commonwealth of Massachusetts is transferring 20,000 lb (9,072 kg) of commercial bluefish quota to the State of Rhode Island from its 2006 quota. By this action, NMFS adjusts the quotas and announces the revised commercial quota for each state involved.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

This document provides notice of a proposed rulemaking for public comment on EPA's National Pollutant Discharge Elimination System (NPDES) Permit Fee Incentive for Clean Water Act Section 106 Grants; Allotment Formula. With this notice, EPA proposes using its Clean Water Act (CWA) Section 106 authority to provide a financial incentive to States to utilize an adequate fee program when implementing an authorized NPDES permit program. EPA proposes to amend its existing CWA Section 106 grant allotment regulation to provide the Agency with the flexibility to allot separately a permit fee incentive amount. This action would not be effective prior to fiscal year 2008.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of dirlotapide solution in dogs for the management of obesity.

The Commission is today proposing new rules designed to provide additional investor protections that would affect pooled investment vehicles, including hedge funds. First, the Commission is proposing a rule that would prohibit advisers to pooled investment vehicles from making false or misleading statements or otherwise defrauding investors or prospective investors in those pooled investment vehicles. Second, the Commission is proposing two rules that would revise the definition of accredited investor as it relates to natural persons. The latter rules would apply solely to the offer and sale of interests in certain privately offered investment pools specified in the rules.

This interim rule lists communities where modification of the Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because of new scientific or technical data. New flood insurance premium rates will be calculated from the modified BFEs for new buildings and their contents.

Base (1% annual chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Orion Corp. The supplemental NADA adds a claim for reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride to labeling for atipamezole hydrochloride injectable solution for dogs.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for the use of doxapram hydrochloride injectable solution in dogs, cats, and horses to stimulate respiration during and after general anesthesia.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Orion Corp. The NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative, analgesic, and preanesthetic in dogs.

EPA is proposing to approve revisions to the Tennessee State Implementation Plan (SIP) submitted by the State of Tennessee, through Tennessee Department of Environment and Conservation, on January 20, 2006. The revisions pertain to the Knox County portion of the Tennessee SIP and include changes to the Knox County Air Quality Regulations Section 46.0``Regulation of Volatile Organic Compounds.'' The changes were made in response to changes made by EPA to corresponding federal law. The change involves the addition of four compounds to the list of compounds excluded from the definition of volatile organic compounds on the basis that they make a negligible contribution to ozone formation. This action is being taken pursuant to section 110 of the Clean Air Act. In the Final Rules Section of this Federal Register, the EPA is approving the State's SIP revisions as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no significant, material, and adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this document. Any parties interested in commenting on this document should do so at this time.

The FAA is adopting a new airworthiness directive (AD) for certain EMBRAER Model ERJ 170 and ERJ 190 airplanes. This AD requires repetitive inspections to detect damaged smoke seals in the aft avionics compartment, repair/replacement if any damage is found, and reinforcement if no damage is found. This AD also requires eventual replacement of all smoke seals in the aft avionics compartment with new, improved seals having new part numbers, which terminates the repetitive inspections. This AD results from a report of damaged smoke seals in the aft avionics compartment of the affected airplanes. We are issuing this AD to prevent smoke from penetrating into the passenger cabin during a fire in the avionics compartment.

EPA is proposing to approve revisions to the Imperial County Air Pollution Control District and South Coast Air Quality Management District portion of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from architectural coatings and organic liquid storage tanks. We are proposing to approve local rules to regulate these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act).

The Safe Drinking Water Act (SDWA), as amended in 1996, requires the United States Environmental Protection Agency (EPA) to establish criteria for a program to monitor unregulated contaminants and to publish a list of contaminants to be monitored every five years. EPA published the first set of contaminants in 1999. This final regulation meets the SDWA requirement by publishing the next set of unregulated contaminants to be monitored and the requirements for such monitoring. This final rule describes the design for the second Unregulated Contaminant Monitoring Regulation (UCMR) cycle (i.e., UCMR 2) of 2007- 2011. EPA is requiring monitoring of 25 chemicals using 5 different analytical methods. UCMR 2 monitoring will occur during 2008-2010. Implementation of this final rule will benefit the environment by providing EPA and other interested parties with scientifically valid data on the occurrence of these contaminants in drinking water, thereby permitting the assessment of the population potentially being exposed and the levels of that exposure. These data are the primary source of occurrence and exposure data for the Agency to determine whether to regulate these contaminants.

This proposed rule would amend HUD's regulations governing the Community Development Block Grant (CDBG) program for non-entitlement areas in the state of Hawaii. Pursuant to statutory authority, the state of Hawaii has elected not to administer funds to units of general local governments located in non-entitlement areas within the state. The statute provides that if Hawaii opts to not assume responsibility for the program, then the Secretary of HUD will make grants to the units of general local government located in Hawaii's non-entitlement areas, employing the same distribution formula as was used under prior regulations. This proposed rule would modify HUD's regulations to clarify how the CDBG program will be implemented in the non-entitlement areas of Hawaii. HUD has also taken the opportunity afforded by this proposed rule to update and streamline the subpart F regulations, particularly with regard to the HUD-administered Small Cities program in New York, which awarded its last competitive grant in Fiscal Year (FY) 1999.

The Department of State proposes to revise its regulations governing the classification of national security information that is under the control of the Department in order to reflect the provisions of a new executive order on national security information and consequent changes in the Department's procedures since the last revision of the Department's regulations on this subject.

EPA is proposing to approve revisions to the Tennessee State Implementation Plan (SIP) submitted by the State of Tennessee, through the Tennessee Department of Environment and Conservation, on December 21, 1999, March 15, 2000, and January 12, 2001. The revisions pertain to the Knox County portion of the Tennessee SIP and include changes to the Knox County Air Quality Regulations Section 13.0``Definitions'' and Section 22.0``Regulation of Fugitive Dust and Materials.'' These revisions are part of Knox County's strategy to attain and maintain the national ambient air quality standards, and are considered by the TDEC to be at least as stringent as the State's requirements. This action is being taken pursuant to section 110 of the Clean Air Act. In the Final Rules Section of this Federal Register, EPA is approving the Tennessee SIP revisions as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this document. Any parties interested in commenting on this document should do so at this time.